Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study (HEPACOLL)

Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study

Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the most effective possible tool for hemostasis allows a bleeding decrease during liver transection and thus could reduce postoperative morbidity.

In the past decade, the improvement of techniques of transection of the hepatic parenchyma was one of the most important factors to ensure the hepatectomy safety. But the clinical performances of these technological innovations (ultrasound dissectors, monopolar radiofrequency probes and dissection devices using pressurized water) remain still unclear.

The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology of "transcollation" combining a source of radiofrequency associated with a conductive liquid (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks of electric arc and overheating met with conventional electrosurgery. This device allows the coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These clinical benefits could be translated by an improvement of the direct and indirect costs associated to the surgery. However the Aquamantys® technology has not been scientifically validated in the context of the hepatic surgery, and this technology is expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment in a generator (Aquamantys Pump Generator®).

Consequently, it is essential to realize a study measuring the clinical and medical economic impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.

Study Overview

• Status: Unknown
• Conditions: Hepatectomy
• Intervention / Treatment: Device: standard bipolar coagulation; Device: Aquamantys® probe for liver hemostasis

Detailed Description

After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study:

• Control group: hepatectomy with conventional hemostasis using standard bipolar coagulation
• Test group: hepatectomy with Aquamantys®

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing elective surgery for liver resection of malignant or benign disease
• Hepatic resection of two or more segments
• No coagulation disorder
• No portal hypertension (platelets ≥ 100 G/L, absence of splenomegaly, absence of portal hypertension varices)
• Obtaining the patient's written consent

Exclusion Criteria:

• Age < 18 years and > 80 years
• ASA score > 3
• Cirrhosis, liver fibrosis > F2, steatosis > 60%, sinusoidal obstruction syndrome
• Cognitive troubles and major disability making impossible to understand the study and signed the informed consent (e.g. dementia, psychiatric disorders like psychosis, speech disorder ...)
• Liver and kidney failure
• Pregnancy and lactating women
• Legal incapacity
• Patients already enrolled in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hepatectomy ( conventional hemostasis ); After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: - Control group: hepatectomy with conventional hemostasis using standard bipolar coagulation	Device: standard bipolar coagulation
Other: hepatectomy with Aquamantys; After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: - Test group: hepatectomy with Aquamantys®	Device: Aquamantys® probe for liver hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood loss during surgery	at day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of liver transection	at day 0
Duration of surgery	at day 0
Duration of hospital stay	at day 1
Number of red blood cells transfusions	at day 0
Number of frozen plasma transfusions	at day 0
Volume of crystalloid and colloid fluids	at day 0
Need of norepinephrine during the surgery	at day 0

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: INNOPATH; MEDTRONIC labs provide the aquamantys® probes for the study.
• Investigators: Principal Investigator: Emmanuel BUC, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: blood loss; Hepatectomy; hemostasis; coagulation; Liver surgery (benign or malign); Resection of 2 or more segments
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: CHU-0156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No